Positron emission tomography (PET) is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is the radioisotope commonly used in oncologic FDG PET imaging procedures.
The rate of FDG decay provides information on glucose metabolism of tissues being studied. As malignancies can cause abnormalities of glucose metabolism, FDG PET evaluation can indicate the probable presence or absence of malignancy based upon observed differences in biologic activity of adjacent tissues.
Section 220.6 of the National Coverage Determination (NCD) Manual establishes the requirement for prospective data collection for FDG PET used in the diagnosis, staging, restaging and monitoring response to treatment for brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers, as well as for cancer indications not previously specified in Section 220.6 in its entirety.
The requestors have asked CMS to reconsider Section 220.6 to end the data collection requirements across all oncologic indications except for monitoring response to treatment.
We have received public input indicating that the current coverage framework which required cancer by cancer consideration of diagnosis, staging, restaging and monitoring response to treatment should be replaced by a more omnibus consideration. Though that coverage framework has been useful, we are open to public input that it be retired and that a general policy could be developed and applied to oncologic FDG PET imaging.
The following sections of the National Coverage Determination Manual currently address solid tumors:
220.6.2 - Lung cancer
220.6.3 - Esophageal cancer
220.6.4 - Colorectal cancer
220.6.5 - Lymphoma
220.6.6 - Melanoma
220.6.7 - Head and neck cancers
220.6.10 - Breast cancer
220.6.11 - Thyroid cancer
220.6.12 - Soft tissue sarcoma
220.6.14 - Brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers
220.6.15 - All other cancer indications not previously specified
We have broadened the scope of this review through an announcement on our website and are soliciting additional public comment on the use of FDG PET imaging for other solid tumors. We are also soliciting public suggestions for possible alternatives to the current coverage framework described above.